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Bio-Rad Laboratories, Inc. has announced the launch of the new Biologics Analysis Workflow for faster, easier, and more reproducible purity assessment of protein-based therapeutics in cGMP-regulated environments.

The Biologics Analysis Workflow consists of the following steps: 1. Separate samples in only 20 minutes using Criterion™ TGX™ precast gels. The higher-throughput, mid-sized format increases reproducibility and reduces costs because fewer gels are needed.

2. Stain proteins with the QC Colloidal Coomassie stain. Capable of detecting nanograms of protein, this ready-to-use stain eliminates the need for preparation, requiring no additional reagents or mixing, which results in increased reproducibility.

4. Analyze results using the new Image Lab 5.0 software. Designed to meet U.S. FDA 21 CFR part 11 compliance requirements, Image Lab automates gel analysis, saving time and ensuring consistency between runs.

A scientist at a global contract research organization (CRO) explains that the ability to calibrate the GS-900 system prior to scanning and take the optical density down to zero offers a significant advantage regarding compliance, because the GS-900 densitometer covers the density range that the CRO reports. He adds that Image Lab software facilitates compliance by allowing easy creation of the sorts of custom data reports that auditors look for.

A recent comparability study by Bio-Rad demonstrates how easily labs can update their protocols to include the GS-900 system and the Biologics Analysis Workflow for compliance with FDA and other regulatory requirements.

Click here to learn more about the Biologics Analysis Workflow and how you can seamlessly integrate the new workflow into your SOPs.